Onco-Innovations Commences Activities to Manufacture Nanoparticle Formulation with Dalton Pharma to Supply Preclinical Animal Studies
Onco-Innovations (OTCQB:ONNVF) has initiated manufacturing activities with Dalton Pharma Services for its proprietary nanoparticle formulation, PEO-b-PBz-CL. This formulation is a crucial component of Onco's drug delivery platform designed to work with their PNKP inhibitor.
The manufacturing process will involve scale-up activities from 10 grams to 350 grams, focusing on optimization and establishing reproducible synthesis methods. Dalton will ensure the formulation meets quality specifications for purity, molecular weight, and residual solvent levels, while generating necessary analytical data for regulatory filings and future GMP manufacturing.
Onco-Innovations (OTCQB:ONNVF) ha avviato attività di produzione con Dalton Pharma Services per la sua formulazione proprietaria a nanoparticelle, PEO-b-PBz-CL. Questa formulazione è un componente cruciale della piattaforma di somministrazione dei farmaci di Onco, progettata per funzionare con il loro inibitore PNKP.
Il processo di produzione includerà attività di scale-up da 10 grammi a 350 grammi, con focus sull’ottimizzazione e sull’istituzione di metodi di sintesi riproducibili. Dalton garantirà che la formulazione soddisfi le specifiche di qualità per purezza, peso molecolare e livelli di solventi residui, generando nel contempo i dati analitici necessari per i filing regolatori e per la futura produzione GMP.
Onco-Innovations (OTCQB:ONNVF) ha iniciado actividades de fabricación con Dalton Pharma Services para su formulación propietaria de nanopartículas, PEO-b-PBz-CL. Esta formulación es un componente crucial de la plataforma de entrega de fármacos de Onco, diseñada para funcionar con su inhibidor de PNKP.
El proceso de fabricación implicará actividades de escalado de 10 gramos a 350 gramos, centradas en la optimización y en establecer métodos de síntesis reproducibles. Dalton garantizará que la formulación cumpla con las especificaciones de calidad para pureza, peso molecular y niveles de disolventes residuales, al tiempo que genera los datos analíticos necesarios para presentaciones regulatorias y futura fabricación GMP.
Onco-Innovations (OTCQB:ONNVF)는 독점 나노입자 제형인 PEO-b-PBz-CL에 대해 Dalton Pharma Services와 제조 활동을 시작했습니다. 이 제형은 PN K P 억제제와 함께 작동하도록 설계된 Onco의 약물 전달 플랫폼의 중요한 구성요소입니다.
제조 공정은 10그램에서 350그램으로의 스케일업을 포함하며 최적화와 재현 가능한 합성 방법의 확립에 중점을 둡니다. Dalton은 순도, 분자량, 잔류 용매 수준에 대한 품질 규격을 충족시키도록 보장하고, 규제 제출 및 향후 GMP 제조에 필요한 분석 데이터를 생성합니다.
Onco-Innovations (OTCQB:ONNVF) a démarré des activités de fabrication avec Dalton Pharma Services pour sa formulation propriétaire à nanoparticules, PEO-b-PBz-CL. Cette formulation est un élément clé de la plateforme de délivrance de médicaments d'Onco, conçue pour fonctionner avec leur inhibiteur PNKP.
Le processus de fabrication impliquera des activités d’échelle de 10 grammes à 350 grammes, en mettant l'accent sur l’optimisation et l'établissement de méthodes de synthèse reproductibles. Dalton veillera à ce que la formulation respecte les spécifications de qualité en matière de pureté, de masse moléculaire et de niveaux de solvants résiduels, tout en générant les données analytiques nécessaires pour les dépôts réglementaires et la fabrication GMP future.
Onco-Innovations (OTCQB:ONNVF) hat mit Dalton Pharma Services Fertigungsaktivitäten für seine proprietäre Nanopartikel-Formulierung, PEO-b-PBz-CL, aufgenommen. Diese Formulierung ist ein wesentlicher Bestandteil der Onco-Plattform für Wirkstoffabgabe, die mit ihrem PNKP-Inhibitor arbeiten soll.
Der Herstellungsprozess wird eine Skalierung von 10 Gramm auf 350 Gramm umfassen, mit Fokus auf Optimierung und Etablierung reproduzierbarer Synthesemethoden. Dalton wird sicherstellen, dass die Formulierung den QualitätsSpezifikationen für Reinheit, Molekulargewicht und Restsolventienwerte entspricht, während gleichzeitig notwendige analytische Daten für regulatorische Einreichungen und die künftige GMP-Herstellung erzeugt werden.
Onco-Innovations (OTCQB:ONNVF) بدأت أنشطة التصنيع مع Dalton Pharma Services من أجل صياغتها النانوية المملوكة، PEO-b-PBz-CL. هذه الصيغة جزء حاسم من منصة توصيل الدواء لدى Onco المصممة للعمل مع مثبِّط PNKP الخاص بهم.
سيتضمن عملية التصنيع توضيع من 10 جرامات إلى 350 جراماً، مع التركيز على التحسين وتأسيس أساليب تخليق قابلة لإعادة الإنتاج. ستتأكد Dalton من أن الصيغة تلبّي مواصفات الجودة من حيث النقاء، والكتلة الجزيئية، ومستويات المذيب المتبقية، بينما تولّد البيانات التحليلية اللازمة لطلبات تنظيمية وللتصنيع GMP في المستقبل.
Onco-Innovations (OTCQB:ONNVF) 已与 Dalton Pharma Services 开始就其自有的纳米颗粒制剂 PEO-b-PBz-CL 进行制造活动。该制剂是 Onco 的药物递送平台的关键组成部分，设计用于与其 PNKP 抑制剂一起工作。
制造过程将包括 从 10 克扩大到 350 克的放大，重点在于优化并建立可重复的合成方法。Dalton 将确保该制剂符合纯度、分子量和残留溶剂水平的质量规格，同时生成监管备案所需的分析数据以及未来 GMP 制造所需的数据。
- Partnership with Dalton Pharma Services, a leading Canadian contract development and manufacturing organization
- Successful initial feasibility demonstration at 10 grams scale
- Planned scale-up to 350 grams production capacity
- Development package will include comprehensive analytical characterization and process documentation
- Product still in early preclinical stage, far from commercialization
- Need to reduce residual catalyst content indicates current manufacturing challenges
VANCOUVER, BC / ACCESS Newswire / September 19, 2025 / Onco-Innovations Limited (CBOE CA:ONCO )(OTCQB:ONNVF )(Frankfurt:W1H) (WKN: A3EKSZ ) (" Onco " or the " Company ") is pleased to announce that Dalton Pharma Services ("Dalton") has commenced activities to manufacture Onco's proprietary nanoparticle formulation, also know as PEO-b-PBz-CL 1 , a key component of the Company's novel drug delivery platform which is designed for use in conjunction with Onco's proprietary Polynucleotide Kinase Phosphatase (PNKP) inhibitor. The manufacturing initiative is intended to generate the nanoparticle material required to advance preclinical studies.
The production campaign will include process optimization and scale-up activities to establish reproducible methods for the synthesis of PEO-b-PBz-CL, while ensuring that the formulation meets quality specifications for purity, molecular weight, and residual solvent levels. Dalton has already demonstrated initial feasibility at the 10 grams scale and will now focus on reducing residual catalyst content and scaling production to 100 grams, followed by a demonstration batch at the 350 grams scale. These activities are designed to provide sufficient quantities of nanoparticle material for formulation development, while also generating the analytical data necessary to support regulatory filings and the eventual transition to Good Manufacturing Practice (GMP) manufacturing.
By engaging Dalton, Onco benefits from the technical expertise and regulatory experience of one of Canada's leading contract development and manufacturing organizations. Dalton's work will provide a comprehensive development package, including full analytical characterization and process documentation, to ensure a smooth path toward clinical readiness of the nanoparticle-formulated platform.
" Advancing the nanoparticle formulation demonstrates will help inform our next phase of development, advancing our pathway toward the clinical opportunities we are determined to reach, " stated Thomas O'Shaughnessy, CEO of Onco-Innovations.
About Onco-Innovations Limited
Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco's mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours.
ON BEHALF OF ONCO-INNOVATIONS LIMITED,
" Thomas O'Shaughnessy "
Chief Executive Officer
For more information, please contact:
Thomas O'Shaughnessy
Chief Executive Officer
Tel: + 1 888 261 8055
investors@oncoinnovations.com
Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the benefits expected to be realized under the agreement with Dalton, and the Company's ability to move forward with its plans for manufacturing and further testing and development of its Technologies, the prospects of the Company, and the Company's business and plans generally, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "potential", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
1poly(ethylene oxide)-block-poly(α-benzyl carboxylate ε-caprolactone)
SOURCE: Onco-Innovations LimitedView the original press release on ACCESS Newswire
FAQ
What is the purpose of Onco-Innovations' partnership with Dalton Pharma Services?
What are the key manufacturing scale-up targets for ONNVF's nanoparticle formulation?
What is PEO-b-PBz-CL and how is it used by Onco-Innovations?
What quality specifications will Dalton ensure for ONNVF's nanoparticle formulation?
How will this manufacturing initiative support Onco-Innovations' regulatory pathway?
